Rasps for Scraping Bone
FDA 510(k) K771745 · Depuy, Inc.
510(k) numberK771745
Submission
- Device name
- Rasps for Scraping Bone
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- September 15, 1977
- Decision date
- September 28, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTR – Rasp
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HTR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K870349 | Biodynamics Femoral Canal Brush #1201HTR · Traditional | Biodynamic Technologies, Inc. | 02/13/1987SE |
| K870333 | Biodynamics Small Joint Brush #1203HTR · Traditional | Biodynamic Technologies, Inc. | 02/13/1987SE |
| K870329 | Acetabular Brush #1202 & Femoral Con. Brush #1202HTR · Traditional | Biodynamic Technologies, Inc. | 02/13/1987SE |
| K813093 | Richards Acetabular BrushHTR · Traditional | Richard'S Medical Equip., Inc. | 11/20/1981SE |
| K812506 | The ArthrofileHTR · Traditional | Dyonics, Inc. | 09/24/1981SE |
| K780771 | Micro RaspsHTR · Traditional | Amsco Co. | 05/16/1978SE |
| K771016 | Intermedullary BrushHTR · Traditional | Howmedica Corp. | 01/12/1978SE |
| K760109 | Prosthesis, Total Hip-RaspHTR · Traditional | Orthopedic Equipment Co., Inc. | 07/20/1976SE |
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Questions and answers
When was Rasps for Scraping Bone cleared by the FDA?
Rasps for Scraping Bone (K771745) received a 510(k) decision of Substantially Equivalent on September 28, 1977, 13 days after the submission was received.
What is the product code of K771745?
The FDA product code is HTR – Rasp, a Class I (low risk) device regulated under 21 CFR 878.4800.